Consulting
Optimising processes requires not only attention to details but also a strategic vision. It is our claim to develop solutions with you together that help on a short-term and enable acting sustainably on a long-term. When different disciplines go into a common direction a well-rounded solution will be the result. Feasible and pragmatic – tailor-made for your company.
Quality Management & GMP
- Quality Strategy
- GMP Compliance & Assessment
- Management Review
- Auditing
- Inspection Preparation
Drug Regulatory Affairs
- Licensing Strategy
- Quality by Design (QbD)
- Post-Approval Change Management (PACM)
- Electronic Common Technical Document (eCTD)
- Technology Transfer
- Scientific-Technical Documentation
- EU-ASMF
- Authority Meetings
Pharma 4.0
- Pharmaceutical Quality System (PQS)
- Quality Risk Management (QRM)
- Knowledge Management (KM)
- Data Integrity
- Digital Maturity
“We cannot direct the wind.
But we can adjust the sails.“
Bertha Calloway

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